Guerbet’s Elucirem (gadopiclenol) Receives the US FDA’s Approval for Contrast-Enhanced Magnetic Resonance Imaging
Shots:
- The US FDA has approved Elucirem for contrast-enhanced MRI
- The approval was based on the 2 P-III studies of gadopiclenol (0.05mmol/kg) vs gadobutrol (0.1mmol/kg) which demonstrated that gadopiclenol leads to non-inferior results in brain and body MRI, contrast enhancement & diagnostic efficacy at half of the gadolinium dosing of other GBCAs, no safety signals were reported & the adverse reactions were similar for both products
- Elucirem is a new macrocyclic gadolinium-based contrast agent with high relaxivity indicated for adults & children aged ≥2yrs. & can be utilized with MRI to detect lesions with abnormal vascularity in CNS & other areas. The product will be marketed by Guerbet in the US in a bottle and pre-filled syringe form
Ref: Guerbet | Image: Guerbet
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